Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk

NCT ID: NCT03246243

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-29
• Study Completion Date: 2021-05-18

Brief Summary

The main goal of this study is to quantitatively assess the sucking and feeding activity of infants at high risk of neurological impairment (preterm infants and term infants at risk of abnormal neurodevelopment) during oral sucking and feeding and correlate it with their underlying neurological impairment for the early diagnosis of brain injury.

Detailed Description

This research will address the current lack of objective tools for the reliable assessment of oral sucking and feeding in clinical practice, and the insufficient evidence that relates early measures of abnormal sucking activity with the underlying neurological impairment.

The main goal of this study is to quantitatively assess the sucking and feeding activity of infants at high risk of neurological impairment (preterm infants and term infants at risk of abnormal neurodevelopment) during oral sucking and feeding and correlate it with their underlying neurological impairment for the early diagnosis of brain injury. We aim to study three groups of infants who are inpatients on the Neonatal Intensive Care Unit (NICU) at Boston Children's Hospital (BCH), the NICU or Newborn Nursery at Beth Israel Deaconess Medical Center (BIDMC), the Special Care Nursery (SCN) or Newborn Nursery at Winchester Hospital as follows: (i) group A consisting of preterm infants (gestational age of <37 weeks), (ii) group B consisting of term infants admitted to the NICU at BCH and BIDMC for therapeutic hypothermia who are at risk of developing hypoxic ischemic injury (HIE); admitted with concern for neonatal stroke; seizures of unknown etiology; and those admitted to the NICU, SCN or Newborn Nursery at BCH, BIDMC and Winchester Hospital at risk of abnormal neurodevelopment such as those with hypoglycemia or neonatal abstinence syndrome (NAS) and; (iii) group C consisting of healthy term infants admitted to the NICU, SCN or nursery who had an initial uncomplicated postnatal course that will serve as the control group. Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly.

Conditions

Hypoxic-Ischemic Encephalopathy; Hypoglycemia; Neonatal Abstinence Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Preterm infants

Group A will consist of preterm infants born \< 37 weeks gestational age. Non-nutritive and nutritive sucking will be assessed using an FDA-approved device (Nfant Feeding Solution) to measure sucking activity. Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly. If a subject undergoes any clinically ordered EEG, EMG, MEG, and MRI throughout the duration of their study participation before the age of three then that data will be collected from their medical record. Additionally, any neurodevelopmental testing data completed up to the age of three will be collected.

nfant feeding solution

Intervention Type: DEVICE

The study will record the sucking activity of the hospitalized infants over time, from their first oral sucking session including non-nutritive and nutritive sucking, until discharge, using an FDA-approved device that equips a typical bottle and nipple commonly used in the NICU with a non-invasive sensor to measure sucking activity. Each infant's nutritive and non-nutritive sucking patterns will be measured, and will comprise the 'sucking session' conducted with the bottle sensor.

Term infants with HIE or at risk of brain injury

Group B will consist of term infants admitted to the NICU for therapeutic hypothermia who are at risk of HIE; admitted with concern for neonatal stroke; seizures of unknown etiology; and those admitted who are at risk of abnormal neurodevelopment such as those with hypoglycemia or NAS. Non-nutritive and nutritive sucking will be assessed using an FDA-approved device (Nfant Feeding Solution) to measure sucking activity. Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly. If a subject undergoes any clinically ordered EEG, EMG, MEG, and MRI throughout the duration of their study participation before the age of three then that data will be collected from their medical record. Additionally, any neurodevelopmental testing data completed up to the age of three will be collected.

nfant feeding solution

Intervention Type: DEVICE

The study will record the sucking activity of the hospitalized infants over time, from their first oral sucking session including non-nutritive and nutritive sucking, until discharge, using an FDA-approved device that equips a typical bottle and nipple commonly used in the NICU with a non-invasive sensor to measure sucking activity. Each infant's nutritive and non-nutritive sucking patterns will be measured, and will comprise the 'sucking session' conducted with the bottle sensor.

Term infants healthy at birth

Group C will consist of healthy term infants from the community and term infants admitted to who had an initial uncomplicated postnatal course that will serve as the control group. Non-nutritive and nutritive sucking will be assessed using an FDA-approved device (Nfant Feeding Solution) to measure sucking activity. Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly. If a subject undergoes any clinically ordered EEG, EMG, MEG, and MRI throughout the duration of their study participation before the age of three then that data will be collected from their medical record. Additionally, any neurodevelopmental testing data completed up to the age of three will be collected.

nfant feeding solution

Intervention Type: DEVICE

The study will record the sucking activity of the hospitalized infants over time, from their first oral sucking session including non-nutritive and nutritive sucking, until discharge, using an FDA-approved device that equips a typical bottle and nipple commonly used in the NICU with a non-invasive sensor to measure sucking activity. Each infant's nutritive and non-nutritive sucking patterns will be measured, and will comprise the 'sucking session' conducted with the bottle sensor.

Interventions

nfant feeding solution

The study will record the sucking activity of the hospitalized infants over time, from their first oral sucking session including non-nutritive and nutritive sucking, until discharge, using an FDA-approved device that equips a typical bottle and nipple commonly used in the NICU with a non-invasive sensor to measure sucking activity. Each infant's nutritive and non-nutritive sucking patterns will be measured, and will comprise the 'sucking session' conducted with the bottle sensor.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Preterm infants with GA<37 weeks
• Term infants with GA>37 weeks and at risk of brain injury
• Healthy term infants with GA= 37-41 weeks, appropriate birth weight, 5 minute Apgar score>7, and an initial uncomplicated postnatal course

Exclusion Criteria

• major congenital anomalies
• craniofacial malformation
• short bowel syndrome

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Winchester Hospital

UNKNOWN

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christos Papadelis

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christos Papadelis, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB-P00023193

Identifier Type: -

Identifier Source: org_study_id